Abstract:
BACKGROUND:The clinical utility of cellular therapies is being investigated in a broad range of therapeutic areas. This phase 1 study represents the first exploration of PDA001, a preparation of cells cultured from human placental tissue, in subjects with Crohn's disease. METHODS:Twelve subjects with active, moderate-to-severe Crohn's disease unresponsive to previous therapy were given 2 intravenous infusions of PDA001 1 week apart, monitored weekly for 5 weeks, and assessed at 6 months, 1 year, and 2 years after infusion. Six subjects received 2 infusions of 2 × 10 cells (low dose), and 6 subjects received 2 infusions of 8 × 10 cells (high dose). RESULTS:Mean baseline Crohn's Disease Activity Index in the low-dose and high-dose groups was 305 and 364, respectively, and mean C-reactive protein was 8 mg/L and 49 mg/L, respectively. All subjects in the low-dose group achieved a clinical response (a Crohn's Disease Activity Index decrease of ≥70 points versus baseline), and 3 achieved remission (a Crohn's Disease Activity Index decrease of ≥100 to <150 points). Two subjects in the high-dose group achieved response, and none met remission criteria. Most adverse events were mild to moderate in severity and included headache, nausea, fever, and infusion site reactions. CONCLUSIONS:PDA001 infusions appear safe and well-tolerated in subjects with treatment-resistant Crohn's disease. A response was seen in all subjects in the low-dose group. The high-dose group, with a higher baseline disease activity, had only 2 responders, suggesting a more treatment-resistant population. A phase 2 study in this patient population is ongoing.
journal_name
Inflamm Bowel Disjournal_title
Inflammatory bowel diseasesauthors
Mayer L,Pandak WM,Melmed GY,Hanauer SB,Johnson K,Payne D,Faleck H,Hariri RJ,Fischkoff SAdoi
10.1097/MIB.0b013e31827f27dfsubject
Has Abstractpub_date
2013-03-01 00:00:00pages
754-60issue
4eissn
1078-0998issn
1536-4844journal_volume
19pub_type
杂志文章,多中心研究abstract:BACKGROUND:Complementary and alternative medicine (CAM) use is highly prevalent among inflammatory bowel disease (IBD patients). We assessed whether its use, both for IBD and for general health, influenced adherence to conventional medications. METHODS:We enrolled 392 IBD subjects in a prospective cohort study and cat...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000773
更新日期:2016-06-01 00:00:00
abstract:BACKGROUND:Ulcerative colitis (UC) negatively affects health-related quality of life (HRQoL), but population-based and long-term data on this topic are scarce. Our aim was to determine the HRQoL in UC patients after a 10-year disease duration. METHODS:UC patients from a population-based inception cohort met at a presc...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1002/ibd.21863
更新日期:2012-08-01 00:00:00
abstract:BACKGROUND:We sought to investigate whether variants in genes involved in bacterial sensing and autophagy (NOD2, TLR5, IRGM, ATG16L1) and the interleukin-23 signaling pathway (IL12B, IL23R, STAT3) were associated with development of antimicrobial antibodies in patients with Crohn's disease (CD). METHODS:A cohort of 61...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1002/ibd.22884
更新日期:2012-09-01 00:00:00
abstract::Colitis-associated colorectal neoplasia (CRN) is a well-known complication of chronic inflammation of the colon either with ulcerative colitis (UC) or colonic Crohn's disease (CD). Studies have shown that inflammatory bowel disease (IBD) patients have an overall higher risk for colorectal dysplasia and cancer compared...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,评审
doi:10.1097/MIB.0000000000000685
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Activation of cannabinoid (CB)(1) receptors results in attenuation of experimental colitis. Our aim was to examine the role of CB(2) receptors in experimental colitis using agonists (JWH133, AM1241) and an antagonist (AM630) in trinitrobenzene sulfonic acid (TNBS)-induced colitis in wildtype and CB(2) recept...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1002/ibd.20960
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:The goal of this study was to determine the rate of work disability, unemployment, and sick leave in an unselected inflammatory bowel disease (IBD) cohort and to measure the effect of working status and disability on the patient's health-related quality of life (HRQOL). MATERIALS AND METHODS:All eligible pa...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/01.MIB.0000218762.61217.4a
更新日期:2006-05-01 00:00:00
abstract::Inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis, are poorly understood disorders affecting the intestinal tract. The current model for disease suggests that genetically susceptible patients develop intolerance to gut microflora, and chronic inflammation develops as a result of environmental i...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000344
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:Crohn's disease is a heterogeneous inflammatory bowel disease. The impact of age at diagnosis on the clinical course of patients varies widely as reported in the Western literature. Using the Vienna Classification, we seek to determine whether young Crohn's disease patients in an Asian population followed a ...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/01.mib.0000195390.11645.7d
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Improved treatment approaches for ulcerative colitis (UC), including novel medications, might reduce the need for colectomy. We performed a retrospective cohort study of adult patients (age 18-64) with UC in the United States to examine time trends for colectomy and biologic use from 2007 to 2016. METHODS:W...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izz247
更新日期:2020-07-17 00:00:00
abstract:BACKGROUND:Inflammatory bowel disease (IBD) is a multifactorial disorder, with the innate and adaptive immune cells contributing to disease initiation and progression. However, the intricate cross-talk between immune cell lineages remains incompletely understood. The role of CD8+ T cells in IBD pathogenesis has been un...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izz191
更新日期:2020-01-06 00:00:00
abstract::Inflammatory bowel diseases (IBDs) are highly heterogeneous in disease phenotype, behavior, and response to therapy. Diagnostic and therapeutic decisions in IBD are based primarily on clinical and endoscopic severity and histopathologic analysis of intestinal biopsies. With this approach, however, only a minority of p...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izaa217
更新日期:2020-09-18 00:00:00
abstract:BACKGROUND:Previous research suggests a link between childhood adversities and inflammatory bowel disease (IBD); however, study limitations prevent generalization of findings. To address this, the current study uses a Canadian population-based sample to investigate the relationship between 3 childhood adversities and 2...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000551
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Multi-matrix (MMx), a new delivery system for mesalazine, seems to release 5-aminosalicyclic acid (5-ASA) preferentially in the sigmoid colon. This study had 2 objectives: (1) to evaluate the therapeutic response to MMx in patients with active left-sided disease and (2) to gain additional insights as to how ...
journal_title:Inflammatory bowel diseases
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1097/01.mib.0000158386.25660.1e
更新日期:2005-05-01 00:00:00
abstract:BACKGROUND:Guidelines mandate screening for latent tuberculosis infection (LTBI) prior to anti-tumor necrosis factor (anti-TNF) therapy in patients with inflammatory bowel disease (IBD). However, many are already on immunosuppressive therapy (IST) that may affect the precision of the Tuberculin skin test (TST). Our aim...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,meta分析
doi:10.1002/ibd.22901
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Many patients with Crohn's disease (CD) are treated with medications, including steroids, immunomodulators, and anti-tumor necrosis factor alpha (anti-TNF-α) agents, at the time of surgery. This study evaluated the effects of these medications on postoperative complications in CD patients. METHODS:This retr...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izz010
更新日期:2019-08-20 00:00:00
abstract:BACKGROUND:Vitamin A is an important regulator of the human immune system, especially in the gut. Recent studies have revealed that retinoic acid (RA) in gut-associated dendritic cells (DCs) enhances the transforming growth factor (TGF)-beta-dependent conversion of naïve T cells into regulatory T (Treg) cells. Thus, RA...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1002/ibd.20934
更新日期:2009-10-01 00:00:00
abstract::Gastrointestinal disorders, although clinically heterogeneous, share pathogenic mechanisms, including genetic susceptibility, impaired gut barrier function, altered microbiota, and environmental triggers (infections, social and behavioral factors, epigenetic control, and diet). Gut microbiota has been studied for infl...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,评审
doi:10.1097/MIB.0000000000000602
更新日期:2016-02-01 00:00:00
abstract:BACKGROUND:We analyzed inflamed mucosal/submucosal layers of ulcerative colitis (UC = 63) and Crohn's colitis (CC = 50), and unexpectedly, we unveiled a pool of free hemoglobin alpha (Hb-α) chain. Patients with colitides have increased reactive oxidative stress (ROS), DNA oxidation products, free iron in mucosa, in pre...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000144
更新日期:2014-09-01 00:00:00
abstract:BACKGROUND:Anxiety is linked with adverse health-related outcomes and increased health-seeking behaviors among patients with chronic illness. Yet, this relationship has received little attention in pediatric inflammatory bowel disease. The aim of this study was to examine whether anxiety symptoms predicted youth at inc...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000864
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Long-term enteral nutrition may maintain clinical and endoscopic remission in patients with Crohn's disease (CD). The aim of this prospective study was to investigate the impacts of long-term enteral nutrition on clinical and endoscopic disease activities and mucosal tissue cytokines in patients with quiesce...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1002/ibd.20238
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVE:Our goal in this multicentric prospective study was 2-fold: first, to test the diagnostic accuracy of ultrasound, color Doppler imaging (CDI), and contrast-enhanced ultrasound (CEUS) in identifying disease activity in patients with Crohn's disease (CD) compared with endoscopy as the reference standard; and, s...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izaa134
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:The mucus gel layer (MGL) lining the colon is integral to exclusion of bacteria and maintaining intestinal homeostasis in health and disease. Some MGL defects allowing bacteria to directly contact the colonic surface are commonly observed in ulcerative colitis (UC). The major macromolecular component of the ...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izaa064
更新日期:2020-08-20 00:00:00
abstract::Crohn's disease (CD) leads to the development of complications through progressive uncontrolled inflammation and the transmural involvement of the bowel wall. Most of the available literature on penetrating CD focuses on the perianal phenotype. The management of nonperianal penetrating complications poses its own set ...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,评审
doi:10.1093/ibd/izx108
更新日期:2018-03-19 00:00:00
abstract::This review covers the use of steroids in the treatment of both ulcerative colitis and Crohn's disease. It looks at controlled trials and uncontrolled trials as to the benefits of this agent in both inducing and maintaining remission. The review also stresses the high incidence of toxicity with prolonged use of steroi...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,评审
doi:10.1097/00054725-200002000-00009
更新日期:2000-02-01 00:00:00
abstract::Crohn disease and ulcerative colitis are complex immune-mediated diseases that are characterized by a heterogeneity in presentation and clinical course. Although various clinical covariates predict adverse outcomes in these patients, they are insufficiently informative. The gut microbiome likely plays a central role i...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izaa071
更新日期:2020-09-18 00:00:00
abstract:Background:Both muscle-related complaints and elevated serum creatine kinase (CK) levels have been reported in patients with inflammatory bowel disease (IBD) treated with infliximab (IFX), mainly as case reports. The aim of this study was to investigate the effect of IFX therapy on serum CK levels in a cohort of Greek ...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izy088
更新日期:2018-05-18 00:00:00
abstract:BACKGROUND:MicroRNAs (miRNAs) are dysregulated in the inflammatory bowel diseases, Crohn's disease (CD) and ulcerative colitis (UC), which arise due to dysfunctional host-microbe interactions and impairment of the barrier function of the intestine. Here, we sought to determine whether circulating miRNAs are biomarkers ...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1097/MIB.0000000000000285
更新日期:2015-03-01 00:00:00
abstract:BACKGROUND:The purpose of the study was to determine the role of fecal calprotectin and lactoferrin in the prediction of inflammatory bowel disease relapses, both in patients with ulcerative colitis (UC) and Crohn's disease (CD), in a large, long-term, follow-up study. METHODS:The prospective multicenter study include...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章,多中心研究
doi:10.1002/ibd.20933
更新日期:2009-08-01 00:00:00
abstract:BACKGROUND & AIMS:Malnutrition with the accumulation of fat tissue and nonalcoholic fatty liver disease (NAFLD) are conditions associated with inflammatory bowel disease (IBD). Visceral fat and NAFLD-related liver dysfunction can both worsen intestinal inflammation. Because the Mediterranean diet (Md) has been shown to...
journal_title:Inflammatory bowel diseases
pub_type: 杂志文章
doi:10.1093/ibd/izaa097
更新日期:2021-01-01 00:00:00
abstract:OBJECTIVES:There is some uncertainty regarding how to best dose and therapeutically monitor 6-mercaptopurine or azathioprine in patients with inflammatory bowel disease. The purpose of this study was to assess the relation between clinical response, 6-mercaptopurine metabolite levels, relative leukopenia, and drug dose...
journal_title:Inflammatory bowel diseases
pub_type: 临床试验,杂志文章
doi:10.1097/00054725-200407000-00003
更新日期:2004-07-01 00:00:00